SAN CARLOS, Calif.--(BUSINESS WIRE)--BioCardia®, Inc., a leader in cardiovascular regenerative medicine, announced today two presentations related to CardiAMP cell therapy at the Cardiovascular Research Technologies (CRT 2016) meeting in Washington DC.
CARDIAMP CELL THERAPY FOR POST ACUTE MYOCARDIAL INFARCTION – THE ALSTER HELIX PHASE I STUDY
Dr. Martin W. Bergmann from Hamburg, Germany presented the clinical results of the ALSTER HELIX PHASE I STUDY. ALSTER HELIX was the first study to assess safety and efficacy of the delivery of a bone marrow cell therapy directly into the heart muscle from within the chamber of the heart, between 21 and 45 days after onset of acute myocardial infarction.
Dr. Bergmann explains, “Despite highly efficient and timely percutaneous revascularization some patients suffer from early onset heart failure symptoms after myocardial infarction most often due to a delay between symptom onset and the patient turning to medical care. These patients are at high risk for deteriorating heart function leading to shortness of breath and fatigue with everyday activities. Regenerative heart therapy may have its biggest impact in this vulnerable phase of myocardial scarring following an infarct; yet intracoronary cell therapy was found to be ineffective. Direct intramyocardial delivery has long been recognized as more efficient for cardiac bone marrow cell therapy yet the field has shied away from employing this approach in post infarct patients due to the associated complex workflow and theoretic safety issues. Our workflow included cardiac MRI > 1 week after successful revascularization allowing for precise analysis of heart function and myocardial thickness. The procedure was scheduled at around 4 weeks after PCI. We performed this feasibility study with the Helix biotherapeutic delivery platform, because of its inherent ease of use, demonstrated safety profile in hundreds of heart failure patients in numerous clinical trials, and improved efficiency. With Helix for delivery, and a point of care cell processing platform, in a single inexpensive one hour procedure, we were able to harvest, process, and deliver a dosage of autologous marrow cells to patients with reduced heart function and symptoms of heart failure despite successful revascularization.
ALSTER HELIX results presented showed no safety issues in nine patients treated. While the patients were at high risk of deteriorating heart function based on their initial cardiac MRI we found a statistically significant and clinically meaningful improvements at twelve month follow-up in New York Heart Association class (2.6±0.5 to 1.3 ± 0.5, p = 0.0002), improvements in BNP levels (362.1± 340.4 to 58.9 ± 45.9 ng/l, p = 0.036), and improvements in left ventricular ejection fraction (40.1±8.0 to 47.4 ± 9.0%, p = 0.02).
Dr. Bergmann further explains, “These results support that intramyocardial injection of bone marrow derived cell therapy using Helix can be used safely in patients with symptomatic heart failure following acute ischemic events. Cell therapy in this subgroup of infarct patients should be studied in a larger randomized controlled trial. The highly efficient delivery of 150 million cells, likely the highest effective dosage ever delivered in this clinical setting through the intramyocardial route, might allow us to overcome previous hurdles with this therapeutic approach.”
CARDIAMP CELL THERAPY FOR HEART FAILURE
On Tuesday, February 23, BioCardia CEO, Dr. Peter Altman, will present the CardiAMP Phase III Heart Failure Trial at the featured Cardiovascular Innovations Symposium. The trial will test a novel comprehensive solution for autologous progenitor and stem cell therapy that includes the CardiAMP Potency Assay, CardiAMP Cell Separator (CS) point-of-care processing platform, and the Helix transendocardial delivery system. CardiAMP cell therapy for the treatment of ischemic systolic heart failure is the first cardiac cell therapy to enter pivotal trials under an investigational device exemption and the first to utilize an inclusion criteria assay of patient cell composition. Medicare has approved the CardiAMP IDE, allowing coverage of the CardiAMP device and the routine care items and services in the trial.
“CardiAMP Therapy is based on the role bone marrow cells have in the normal cardiac repair process after an injury to the heart,” said Dr. Peter Altman, PhD, CEO of BioCardia. “The CardiAMP program in Heart Failure presents a potential solution to issues with autologous cell variability. Dr. Bergmann’s new study provides our first clinical support for partners working in this indication using Helix as a delivery solution. It may enable CardiAMP cell therapy to advance in the indication of acute infarction under the same regulatory pathway with the Medicare reimbursement designation that CardiAMP cell therapy has for the indication for heart failure.”
BioCardia, Inc., headquartered in San Carlos, CA is a privately held company developing regenerative biologic therapies to treat cardiovascular disease. The Company's current products include the Helix™ transendocardial delivery system and the Morph® steerable guide and sheath catheter portfolio. BioCardia partners with other biotherapeutic companies to provide its Helix systems and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.